Device and method for treating urinary incontinence in females

Abstract

Provided herein is a novel and useful device and method for locally delivering and controllably releasing oxybutynin in the cervical region of a female. A device of the invention comprises a ring comprising trifluoropropylmethyl/dimethyl siloxane elastomer. A pharmaceutical composition comprising oxybutynin and an excipient is placed within a bore located in the ring, wherein the bore runs from the surface of the ring into the ring. The ring has a sufficient size such that it can be inserted into the vaginal canal of a female. A cap comprising is placed over the bore at the surface of the ring in order to contain the pharmaceutical composition within the bore. When the ring is inserted into the vaginal canal, the trifluoropropylmethyl/dimethyl siloxane elastomer controllably releases and locally delivers a therapeutically effective amount of oxybutynin to the detrusor muscle to treat the female's urinary incontinence.

What is claimed is:  
     
         1 . A method of treating urinary incontinence in a female in need of such treatment comprising providing a single application which controllably administers a therapeutically effective amount of oxybutynin intravaginally over a period of at least seven days.  
     
     
         2 . A method in accordance with  claim 1 , wherein said therapeutically effective amount of oxybutynin is administered intravaginally over a period of from seven to about twenty-eight days.  
     
     
         3 . A method in accordance with  claim 1 , wherein said therapeutically effective amount of oxybutynin is administered intravaginally over a period of at least twenty-eight days.  
     
     
         4 . A method in accordance with  claim 1 , wherein oxybutynin is administered at the rate of about 0.5 to about 5.0 mg/day.  
     
     
         5 . A method in accordance with  claim 2 , wherein oxybutynin is administered at the rate of about 0.5 to about 5.0 mg/day.  
     
     
         6 . A method in accordance with  claim 3 , wherein oxybutynin is administered at the rate of about 0.5 to about 5.0 mg/day.  
     
     
         7 . A method in accordance with  claim 3 , wherein said oxybutynin is administered via a ring having a surface and a bore which runs from said surface into said ring, said bore containing a pharmaceutical composition comprising oxybutynin, said ring comprising trifluoropropylmethyl/dimethyl siloxane elastomer that controllably releases a therapeutically effective amount of oxybutynin by passage from said bore through said elastomer, said ring having a sufficient size such that it can be inserted into the vaginal canal of said female.  
     
     
         8 . A method of simultaneously treating urinary urge incontinence and urinary stress incontinence in a female in need of such treatment comprising placing in the vagina of said female, in a single application, a pessary device with a suitable size and shape for treating urinary stress incontinence said device controllably releasing a therapeutically effective amount of oxybutynin over a period of at least seven days to treat urinary urge incontinence.  
     
     
         9 . A method in accordance with  claim 8 , wherein said device comprises a ring having a surface and a bore which runs from said surface into said ring, said bore containing a pharmaceutical composition comprising oxybutynin, said ring comprising trifluoropropylmethyl/dimethyl siloxane elastomer that controllably releases a therapeutically effective amount of oxybutynin by passage from said bore through said elastomer.  
     
     
         10 . A method in accordance with  claim 8 , wherein said device controllably administers a therapeutically effective amount of oxybutynin intravaginally over a period of seven to about twenty-eight days.  
     
     
         11 . A method in accordance with  claim 8 , wherein said device controllably administers a therapeutically effective amount of oxybutynin intravaginally over a period of at least twenty-eight days.  
     
     
         12 . A method in accordance with  claim 9 , wherein said pharmaceutical composition comprises about 60% by weight oxybutynin and about 40% by weight of an excipient, wherein the excipient comprises tin catalyzed silicone polymer.  
     
     
         13 . A method in accordance with  claim 8 , wherein said therapeutically effective amount of oxybutynin is about 0.5 to about 5.0 mg/day.  
     
     
         14 . A method in accordance with  claim 10 , wherein said therapeutically effective amount of oxybutynin is about 0.5 to about 5.0 mg/day.  
     
     
         15 . A method in accordance with  claim 11 , wherein said therapeutically effective amount of oxybutynin is about 0.5 to about 5.0 mg/day.  
     
     
         16 . A device for locally delivering and controllably releasing oxybutynin to the cervical region of a female to treat urinary incontinence for an extended period in a single application, said device comprising: 
 (a) a ring having a surface, and a bore which runs from said surface into said ring, wherein said ring comprises trifluoropropylmethyl/dimethyl siloxane elastomer, and is of a sufficient size such that it can be inserted into the vaginal canal of said female;    (b) a pharmaceutical composition located within said bore, wherein said 
 pharmaceutical composition comprises oxybutynin and an excipient; whereupon, upon insertion of said ring into said vaginal canal, an amount of oxybutynin therapeutically effective to treat urinary incontinence is controllably released from the ring for a period of at least twenty eight days.  
   
     
     
         17 . A device in accordance with  claim 16 , wherein oxybutynin is released therefrom at the rate of about 0.5 to about 5.0 mg. per day.